1. The FDA and Medical Devices
Effective Use of FDA Evidence
And 510(k) Clearance Data
In Medical Device
Product Liability Litigation
ABA Section of Litigation
Regional CLE Workshop
Philadelphia, PA
November 4, 2016

2. Our Panel: Carrie Watt Teleflex Incorporated Marta L. Villarraga
Wayne, PA
Marta L. Villarraga
Exponent, Inc.
Philadelphia, PA
Michael Anderton
Tucker Ellis LLP
Cleveland, OH
Moderator:
Robert R. Simpson
Shipman & Goodwin LLP
Hartford, CT

3. Yes or No? Will FBI Director Comey share any further information about the s recovered during the Anthony Weiner/Huma Abedin investigation?
Yes No

4. Choose One: Who will have the most significant impact on medical device litigation in the next four years?
Donald Trump
Hillary Clinton
Notorious RBG (Justice Ruth Bader Ginsberg)
ABA Section of Litigation

5. True or False? 510(k) is considered a loophole/rubber stamp by some to get a medical device to market without adequate testing.
True
False

6. True or False? 510(k) is the most often used regulatory pathway to get medical devices to the market.
True
False

7. True or False? Regulatory evidence is always admissible in medical device cases because it forms the framework for devices being cleared or approved.
True
False

8. True or False? A sound trial strategy is a game plan that assumes regulatory evidence being admitted.
True
False

9. True or False? There is no in vivo testing through the 510(k) process.

10. The 510(k) Framework

11. 510(k) v. Pre Market Approval (PMA)

12. 510(k) v. Pre Market Approval (PMA)
Premarket Notification
510(k)
Premarket Approval
PMA
New device is substantially equivalent to a legally marketed device that does not require a PMA
Evidence (usually clinical data) providing reasonable assurance that new device is safe and effective
Less stringent – clinical data is not required
Most stringent type of premarket review
Faster FDA decision
Slower FDA decision
Standard Fee: $4,690 (FY2017)
Standard Fee: $234,495 (FY 2017)
FDA Clearance
FDA Approval

13. Choose One: How often do you believe that there is internal tension on whether a product should proceed through 510(k) v. PMA?
< 25% of the time
25-50% of the time
51-75% of the time
>75% of the time

14. 510(k) Testing

15. Yes or No? Do you ever have in vivo human or animal testing as part of the 510(k) Application?

16. Testing as part of the 510(k)
What is required?
Can in vivo human or animal testing be part of the 510(k) submission?

17. Hypothetical
Trump Women's Healthcare wants to introduce a new medical device to the market, the HRC. The company debates whether to do a line extension, seek 510(k) clearance, or secure approval through a PMA. Trump WHC performs 100 tests on HRC. Seventy of the tests show significant superior performance over the predicate device. Fifteen tests show that the device performs at the same level as the predicated device. Fifteen tests also show that the device performs inferior to the predicate device.
Trump WHC decides to seek 510 (k) clearance from the FDA. The FDA gives Trump the clearance to market and sell HRC.
Four years after the sale of HRC, the product is the subject of an MDL.

18. 510(k) Safety Risk or Safe and Effective?

19. Safety Risk
The 510(k) “pathway does not consider safety and effectiveness…” Brent M. Ardaugh et al., The 510(k) Ancestry of a Metal-on-Metal Hip Implant, 368(2) N. Engl. J. Med. 97 (2013).

20. “Because of this loophole, companies that market these devices are often legally able to obtain clearance without demonstrating safety and effectiveness through clinical studies….” Brent M. Ardaugh et al., The 510(k) Ancestry of a Metal-on-Metal Hip Implant, 368(2) N. Engl. J. Med. 97 (2013).

21. In re Zimmer Nexgen Knee Implant Prods. Liab. Litig.
Safety Risk
“FDA’s finding of substantial equivalence, as a matter of law, is not a safety determination.“
In re Zimmer Nexgen Knee Implant Prods. Liab. Litig.
2015 WL , at *14-15

22. Safe and Effective Substantial Equivalence is the standard
“Safe and Effective” is part of the 510(k) Review

23. Admissibility of 510(k) Clearance

24. Agree or Disagree? Trump WHCI wants testimony at trial that HRC was cleared through the 510(k).
It depends

25. Admissibility
KEEP IT OUT
KEEP IT IN

26. Impact of 510(k) Evidence or Lack Thereof at Trial

27. Impact Be Ready! Stay Ready!
You don’t know how the Court will rule.
Cases excluding admission of 510(k) evidence
In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prod. Liab. Litig. 810 F.3d 913 (4th Cir. 2016).
In re Zimmer Nexgen Knee Implant Prods. Liab. Litig., No. 11-md-02272, 2015 WL , at *14-15 (N.D. Ill. Aug. 21, 2015)
Cases admitting 510(k) evidence
Block v. Woo Young Med. Co., Ltd., 937 F. Supp. 2d 1028, 1047 (D. Minn. 2013).
McClellan v. I-Flow Corp., No. 07-cv-01309, 2010 WL (D. Or. Oct. 7, 2010).

28. Compliance

29. Compliance Compliance Issues Post Clearance 522 Submissions
Withdrawals
Recalls
Changing in
Classification

30. Final Thoughts
And Questions

31. Thank You ! Our Panel: Carrie Watt Michael Anderton
Teleflex Incorporated
Wayne, PA
Michael Anderton
Tucker Ellis LLP
Cleveland, OH
Marta L. Villarraga
Exponent, Inc.
Philadelphia, PA
Robert Simpson
Shipman & Goodwin LLP
Hartford, CT
Thank You !